Initializing
Initializing
Indian pharma SMEs spend weeks rebuilding compliance documentation for every shipment, and one FDA or Schedule M rejection can wipe out months of margin. Pratyaksh turns your ambient batch records, cold chain sensor logs, driver records, and field data into audit-ready artifacts. The document is ready before the inspector asks. Your QA reviews and signs. The shipment goes through.
Any Format
Batch records, sensor logs, PDFs
QA Signs Off
AI reviews first, your team approves
Audit-Ready
Built for audit readiness, every shipment
Your data stays within your boundary and is never shared with third parties. Purpose-built for Indian pharma and food exporters who cannot afford a single compliance breach.
Every request is verified. No implicit trust, no open pathways, even within your own network.
AES-256 encryption at rest and in transit. Your data is mathematically sealed from end to end.
Every generated artifact is timestamped and cryptographically signed. Traceable from field data input to QA sign-off.
Regulatory Standards Supported
India GMP: logistics documentation and deviation management for pharmaceutical distribution
US Good Distribution Practice: logistics evidence standards for pharma and food export shipments
WHO guidelines for ambient and temperature-sensitive products: internationally accepted documentation for export acceptance
Pratyaksh AI is regulatory AI infrastructure for Indian pharma and food exporters. It transforms fragmented supply chain data (ambient batch records, cold chain sensor logs, PDFs) into audit-ready compliance documentation for Schedule M, FDA GDP, and WHO standards — with human QA sign-off built into every workflow.
Pratyaksh AI generates compliance artifacts for Schedule M (India), FDA GDP (USA), and WHO standards (for both ambient and cold chain products). The system adapts to the documentation requirements of any regulatory body your shipments need to satisfy.
When an excursion or deviation is detected (in temperature sensors or ambient logistics records), Pratyaksh AI automatically maps the event, correlates it with driver logs and batch records, generates a CAPA report and deviation document, then routes it to your QA team for sign-off.
Yes. Pratyaksh AI uses a zero-trust architecture with end-to-end encryption and immutable audit logs. Your data stays within your boundary and is never shared with third parties.
Pratyaksh AI ingests any format: CSV sensor exports, PDF trip sheets, scanned manual records, WhatsApp photos, and structured data files. The system normalises all inputs before generating compliance documents.
No. Pratyaksh AI handles the data structuring, AI review, and document generation. Your QA team receives a fully prepared, pre-reviewed compliance artifact and retains final sign-off authority. Human oversight is built into every workflow.
We don't ask you to replace your current QA process. Let Pratyaksh run in the background, in parallel with your manual paperwork. We'll prove our engine catches the compliance gaps your manual process misses—with zero disruption to your current operations.
Currently accepting Indian pharma and food exporters looking to solve compliance documentation without disrupting existing operations.
How It Works
Scroll to exploreYour team signs off. The admin work doesn't reach them.
Feed in whatever field data you have. Sensor CSV exports, PDF trip reports, handwritten driver logs, and WhatsApp voice notes/photos. Pratyaksh works with what your operation already produces, not what an ideal operation would produce.
Pratyaksh structures the evidence chain, generates the compliance artifact, then reviews its own output. It checks for missing fields, timestamp gaps, chain-of-custody inconsistencies, and alignment with Schedule M and FDA GDP requirements. Ensures 100% ALCOA+ Data Integrity. By the time it leaves the engine, the document is already self-verified.
Your QA team receives a pre-validated, regulation-aligned document, not a draft to fact-check. They apply judgment, add context only they have, and sign off. Accountability stays with your team. The administrative burden does not.
The Gap
Sensor CSV exports, PDF trip reports, handwritten driver logs, and WhatsApp voice notes/photos. Pratyaksh ingests what your operation already produces. No new infrastructure required.
Temperature breaches reconstructed as structured events: start time, duration, extent of deviation, affected product, and chain-of-custody at the time.
CAPA reports, deviation logs, and investigation summaries generated pre-formatted to Indian GMP requirements. Ready for inspection without manual reformatting.
Structure export compliance evidence (ambient and cold-chain) to satisfy FDA Good Distribution Practice requirements. Documented response, corrective action, and deviation history included.
Your supply chain records are not shared with third-party models or stored on public cloud. On-premise deployment available for operations with strict data residency requirements.
After generating the compliance artifact, Pratyaksh reviews its own output for gaps and regulatory alignment. Every final document undergoes human-in-the-loop validation, combining automated speed with human accuracy.
Documentation in Action
Illustrative example of the Pratyaksh workflow.